Telbivudine in children/ adolescents with compensated chronic HBV

• Research type

  Research Study

• Full title

  A randomized, double-blind, 104-weeks treatment study to evaluate the efficacy, safety, tolerability and pharmacokinetics of telbivudine oral solution and tablets in children and adolescents with compensated HBeAg-positive and negative chronic hepatitis B virus infection

• IRAS ID

  149334

• Contact name

  Deirdre Kelly

• Contact email

  deirdre.kelly@bch.nhs.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-004942-14

• Clinicaltrials.gov Identifier

  NCT02058108

• Research summary

  Hepatitis B is an infection of the liver caused by the hepatitis B virus. In some cases the infection becomes chronic. Chronic hepatitis B (CHB) can lead to liver failure and liver cancer.
  There are several medicines available for CHB in adults, but there are currently no approved medicines for children.

  Telbivudine is an approved medicine for CHB in adults in the UK, but it is not approved for children under 18 years. Telbivudine works by reducing the amount of virus in the body (viral load). The aim of this study is to see whether telbivudine is safe and effective at reducing viral load in children and adolescents. This will be assessed by measuring the viral load after 6 months, 1 year and 2 years of treatment. The study will last for up to 2 years and there will be 14 study visits. Study medicine will be taken once daily (as a tablet or liquid depending on patient age and weight).

  The first 6 months of the study will be placebo controlled; 83% of patients will be randomly assigned to receive Telbivudine and 17% will receive placebo (a dummy drug). During this time neither the patients nor the researchers will know which group they are in.
  After 6 months, patients will find out their treatment group and the viral load will be measured:
  • Patients on telbivudine with a low viral load will continue on telbivudine.
  • Patients on telbivudine with a high viral load will stop taking part in the study.
  • Patients on placebo may start to receive telbivudine either immediately or up to 12 months later depending on their disease status.

  About 150 children and adolescents worldwide will take part in this study which is sponsored by Novartis.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/0139

• Date of REC Opinion

  9 May 2014

• REC opinion

  Favourable Opinion